(316 days)
No
The summary describes a mechanical device (microclips) and focuses on its material properties, sizes, and MRI compatibility testing. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is described as designed for "occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures," which defines it as a surgical tool used to treat a condition rather than a device intended for therapy.
No
The document describes a surgical microclip used for occluding blood vessels during surgery, which is a therapeutic device rather than a diagnostic one.
No
The device description clearly states it is a physical medical device made from a cobalt-chromium-molybdenum alloy and is available in different sizes. The performance studies also focus on physical properties like MRI compatibility and sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed for the "occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures." This describes a surgical intervention performed directly on the patient's body.
- Device Description: The description reinforces the surgical nature of the device, mentioning it's manufactured from a metal alloy and used for occlusion.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (in glass, or outside the living organism).
- Performance Studies: The performance studies focus on the device's safety and compatibility within the body (MRI compatibility, sterilization). This is consistent with a surgical implant or instrument, not an IVD.
Therefore, the Sugita AVM Microclips are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures.
Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.
Product codes
HCH
Device Description
The Sugita AVM Microclips were cleared by the FDA through 510(k) K960037. The Sugita AVM Microclips are manufactured from Elgiloy, a cobalt-chromiummolybdenum alloy. They are designed for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. The Sugita AVM Microclips are available in the following sizes: 2mm, 3mm, 4mm and 5mm. Other than the modifications identified above, there have been no other changes to the Sugita AVM Microclips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fragile capillary vessels, arteriovenous malformations, and other analogous venous structures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Testing:
-
Study Type: MRI Compatibility Testing – Magnetic Field Interaction (force)
-
Sample Size: Not Specified
-
Key Results: Testing according to ASTM F2052-15 -translational attraction determined to be 14°. Force no greater than gravitational field.
-
Study Type: MRI Compatibility Testing – Magnetic Field Interaction (torque)
-
Sample Size: Not Specified
-
Key Results: Testing according to ASTM F2213-17 – torque showed no movement or alignment. Magnetically induced torque is not substantial and requires no further evaluation.
-
Study Type: MRI Compatibility Testing – MRI Related Heat Testing
-
Sample Size: Not Specified
-
Key Results: Testing according to ASTM F2182-19 – maximum temperature rise of 1.5°C after 15 min. of continuous scan. Maximum Whole Body Averaged SAR 2-W/Kg for 60 min. continuous RF exposure.
-
Study Type: MRI Compatibility Testing - Imaging Artifact Testing
-
Sample Size: Not Specified
-
Key Results: Testing according to ASTM F2119-2013 – image artifact extends approx. 10mm from implant with 3-Tesla gradient echo pulse sequence. The presence of this implant produces an imaging artifact. Therefore, should carefully select pulse sequence parameters if the implant is located in the area of interest.
-
Study Type: MRI Compatibility Testing - Spatial Gradient Magnetic Field Testing
-
Sample Size: Not Specified
-
Key Results: 5mm Sugita AVM Microclips were attached to a porcine blood vessel in order to conduct a digital force gauge-based Pull-Test. Testing supports using a value of 2,000 gauss/cm (20-T/m) for the MRI related labeling of the Sugita AVM Microclips.
-
Study Type: Steam Sterilization Validation Testing
-
Sample Size: Not Specified
-
Key Results: Testing according to ISO 17665-1 was performed to validate steam sterilization parameters for the Sugita AVM Microclips using an FDA cleared nonwoven wrap to a sterility assurance level of (SAL) of 10-6. Validated steam sterilization parameters are provided in the product labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).
0
March 2, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Mizuho America, Inc. Richard Chadwick Senior Manager, Operations and QA 30057 Ahern Avenue Union City, California 94587
Re: K211183
Trade/Device Name: Sugita AVM Microclips Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: Class II Product Code: HCH Dated: January 25, 2022 Received: January 31, 2022
Dear Richard Chadwick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradvan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K211183
Device Name Sugita AVM Microclips
Indications for Use (Describe)
The Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures.
Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
[X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image contains the logo for Mizuho America, Inc. The logo features a blue circular graphic on the left, followed by the word "MIZUHO" in large, bold, blue letters. Below "MIZUHO" is the text "Medical Innovation" in a smaller font. Underneath that is the text "Mizuho America, Inc." in a similar font size.
K211183
510(k) SUMMARY
Applicant Information:
| Owner Name: | Mizuho America, Inc. |
|---|---|
| Address: | 30057 Ahern Avenue |
| Union City, CA 94587 | |
| Phone number: | +1(510) 324-4500 |
| Establishment Registration Number: | 1223656 |
| Contact Person: | Richard Chadwick |
| Date Prepared: | February 28, 2022 |
| Device Information: | |
| Device Classification: | Class II |
| Trade Name: | Sugita AVM Microclips |
| Common name: | Aneurysm Clip |
| Classification name: | Aneurysm Clip |
| Regulation number: | 882.5200 |
| Product Code: | HCH |
Predicate Device:
Sugita AVM Microclips (K960037).
Device Modification:
The following changes have been made to the Sugita AVM Microclips:
- . The device has been demonstrated to be safe for imaging in both 1.5- Tesla and 3-Tesla MR systems.
- New parameters for steam sterilization are provided for end users.
Device Description:
The Sugita AVM Microclips were cleared by the FDA through 510(k) K960037. The Sugita AVM Microclips are manufactured from Elgiloy, a cobalt-chromiummolybdenum alloy. They are designed for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. The Sugita AVM Microclips are available in the following sizes: 2mm, 3mm, 4mm and 5mm. Other than the modifications identified above, there have been no other changes to the Sugita AVM Microclips.
4
Image /page/4/Picture/1 description: The image contains the logo for Mizuho Medical Innovation. The logo features a blue circular graphic with white lines emanating from the center, resembling a stylized globe or sun. To the right of the graphic is the word "MIZUHO" in a bold, blue sans-serif font. Below "MIZUHO" are the words "Medical Innovation" in a smaller, lighter font, followed by "Mizuho America, Inc." in a similar font.
Indications for Use:
The Sugita AVM Microclips have the same Indications for Use as the predicate device.
The Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures.
Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.
Comparison of Technological Characteristics to the Predicate Device:
Both the Sugita AVM Microclips and the predicate device have the same intended use. Both are intended for occlusion of small vessels in Arteriovenous Malformations (AVM's) and other similar structures.
The materials, design, technological characteristics and operating principles of the current device are unchanged from the predicate cleared through K960037. See the table below.
Substantial equivalence in materials, technological characteristics, and performance of the Sugita AVM Microclips to the predicate device is outlined in the table below:
| Product | Sugita AVM Microclips | Sugita AVM Microclips | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device – K211183 | K960037 | |
| Manufacturer | Mizuho America, Inc. | Mizuho America, Inc. | |
| Materials | Elgiloy (cobalt-chromium- | ||
| molybdenum alloy – ASTM | |||
| F1058) | Elgiloy (cobalt-chromium- | ||
| molybdenum alloy – ASTM | |||
| F1058) | SAME | ||
| Technological | |||
| Characteristics | |||
| Designed with a | |||
| predetermined | |||
| holding force | Holding force of 50 to 70g | Holding force of 50 to 70g | SAME |
| Various Sizes for | |||
| specific | |||
| requirements | Four Sizes Available – | ||
| 2mm, 3mm, 4mm and 5mm | Four Sizes Available – | ||
| 2mm, 3mm, 4mm and 5mm | SAME | ||
| Delivery to | |||
| Surgical Site | Sugita Microclip Applier | ||
| designed specifically for | |||
| Sugita AVM Microclips to | |||
| aid in delivery to surgical | |||
| site | Microclip Applier designed | ||
| specifically for Sugita AVM | |||
| Microclips to aid in delivery | |||
| to surgical site | SAME |
5
Image /page/5/Picture/0 description: The image contains the logo for Mizuho Medical Innovation. The logo consists of a circular graphic on the left and the word "MIZUHO" in blue, bold letters on the right. Below the word "MIZUHO" is the phrase "Medical Innovation" in smaller, lighter-colored letters. The circular graphic appears to be a stylized representation of a medical device or technology.
| Product | Sugita AVM Microclips | Sugita AVM Microclips | |
|---|---|---|---|
| 510(k) number | Subject Device – K211183 | K960037 | |
| Manufacturer | Mizuho America, Inc. | Mizuho America, Inc. | Conclusion |
| Steam Sterilized | |||
| by end user | Cycle Type: Pre-vacuum | ||
| • Temperature: 132°C | |||
| • Exposure Time: 4 min. | |||
| • Drying Time: 20 min. |
• Temperature: 134°C
• Exposure Time: 3 min.
• Drying Time: 20 min. | Cycle Type: Pre-vacuum
• Temperature: 252°F
• Exposure Time: 20 minutes | Substantially
Equivalent |
| Performance
Testing | | | |
| MRI Safety | MR Conditional for Use in
Both 1.5T and 3T MR
Systems Based on
Testing:
-Magnetic Field
Interactions
-MRI Related Heating
-MRI Artifact Test | MR Conditional for Use in
1.5T MR Systems | Substantially
Equivalent |
Non-clinical Performance Testing
Performance testing was conducted to demonstrate the safety of the Sugita AVM Microclips for imaging in both 1.5-Tesla and 3-Tesla MR Systems and to provide labeling for MRI safety of the device conforming to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment and Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, Guidance for Industry and Food and Drug Administration Staff, document issued on May 20, 2021.
Additionally, sterilization validation testing was conducted to provide recommended steam sterilization parameters for the device.
| Test | Test Summary | Conclusions |
|---|---|---|
| MRI Compatibility Testing – | ||
| Magnetic Field Interaction (force) | Testing according to ASTM | |
| F2052-15 -translational | ||
| attraction determined to be 14°. | Force no greater than | |
| gravitational field. | ||
| MRI Compatibility Testing – | ||
| Magnetic Field Interaction | ||
| (torque) | Testing according to ASTM | |
| F2213-17 – torque showed no | ||
| movement or alignment. | Magnetically induced torque is | |
| not substantial and requires no | ||
| further evaluation. | ||
| MRI Compatibility Testing – MRI | ||
| Related Heat Testing | Testing according to ASTM | |
| F2182-19 – maximum | ||
| temperature rise of 1.5°C after 15 | ||
| min. of continuous scan. | Maximum Whole Body Averaged | |
| SAR 2-W/Kg for 60 min. | ||
| continuous RF exposure. |
Non-clinical Performance Testing Summary
6
Image /page/6/Picture/0 description: The image shows the logo for Mizuho Medical Innovation. The logo consists of a blue circular graphic on the left, followed by the word "MIZUHO" in large, bold, blue letters. Below the word "MIZUHO" are the words "Medical Innovation" in smaller, thinner, black letters. The circular graphic on the left appears to be a stylized representation of a globe or sphere with curved lines.
| MIZUNO America, Inc.
MRI Compatibility Testing -
Imaging Artifact Testing | Testing according to ASTM
F2119-2013 – image artifact
extends approx. 10mm from
implant with 3-Tesla gradient
echo pulse sequence. | The presence of this implant
produces an imaging artifact.
Therefore, should carefully select
pulse sequence parameters if the
implant is located in the area of
interest. |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MRI Compatibility Testing -
Spatial Gradient Magnetic Field
Testing | 5mm Sugita AVM Microclips were
attached to a porcine blood vessel
in order to conduct a digital force
gauge-based Pull-Test. | Testing supports using a value of
2,000 gauss/cm (20-T/m) for the
MRI related labeling of the
Sugita AVM Microclips. |
| Steam Sterilization Validation
Testing | Testing according to ISO 17665-
1 was performed to validate
steam sterilization parameters for
the Sugita AVM Microclips using
an FDA cleared nonwoven wrap
to a sterility assurance level of
(SAL) of 10-6. | Validated steam sterilization
parameters are provided in the
product labeling. |
Shelf-life
The Sugita AVM Microclips do not have a shelf life because they are provided non-sterile and are constructed of inert materials. Performance data are not needed to establish maintenance of device performance over the shelf life of the Sugita AVM Microclips because the materials of construction of these products are highly stable metal allovs with a long history of use in surgical implants.
Biocompatibility
The proposed changes do not impact the contact duration or biocompatibility profile of the Sugita AVM Microclips.
Conclusion
The modified Sugita AVM Microclips subject to this submission are substantially equivalent to the predicate. Sugita AVM Microclips, in the following ways: they have the same intended use and Indications for Use, the same technological characteristics and operating principles, and incorporate the same design and materials.
Performance testing has demonstrated that the Sugita AVM Microclips are substantially equivalent to the predicate and are safe for imaging in both 1.5- Tesla and 3-Tesla MR systems. In addition, validated parameters for steam sterilization and cleaning are provided to update the instructions for end users of the device.
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